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Recruiting NCT06558227

Study of ZG005 Combined With Bevacizumab Versus Sintilimab Combined With Bevacizumab in Advanced Hepatocellular Carcinoma

Phase II Interventional Hepatocellular Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ZG005 for Injection, Bevacizumab, Sintilimab, Bevacizumab.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Multicenter, Randomized, Open-label Phase II Study of ZG005 Combined With Bevacizumab Versus Sintilimab Combined With Bevacizumab for First-line Treatment of Advanced Hepatocellular Carcinoma

Overview

This study is a randomized, open-label, positive-controlled, multicenter phase II clinical trial. It evaluates the efficacy and safety of ZG005 combined with Bevacizumab compared to Sintilimab combined with Bevacizumab in first-line treatment for patients with advanced hepatocellular carcinoma.

Interventions

  • Biological ZG005 for Injection
    10 mg/kg or 20 mg/kg administered intravenously Q3w
  • Biological Bevacizumab
    15 mg/kg administered intravenously Q3w
  • Biological Sintilimab
    200 mg administered intravenously Q3w
  • Biological Bevacizumab
    15 mg/kg administered intravenously Q3w

Primary outcome measures

  • progression free survival,PFS [Time frame: through study completion, up to 2 year]

Eligibility criteria

Inclusion criteria

  • Fully understand the study and voluntarily sign the informed consent form.
  • 18-75 years of age;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
  • Life expectancy ≥ 12 weeks.

Exclusion criteria

  • Patients were deemed unsuitable for participating in the study by the investigator for any reasons.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • West China Hospital of Sichuan University — Chengdu

Identifiers

NCT: NCT06558227 · ZG005-005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗